The U.S. Food and Drug Administration (FDA) has approved the Promega OncoMate MSI Dx Analysis System as a companion diagnostic designed to identify patients with microsatellite stable endometrial carcinoma who may benefit from treatment with Merck’s anti-PD-1 therapy called KEYTRUDA, plus an inhibitor called LENVIMA, the company announced today.

“This approval underscores the critical role diagnostics play in accurately matching the right patients, at the right time with the right therapy,” Promega Global Clinical Market Director Alok Sharma said in a statement. “We are committed to delivering reliable tools that guide clinical decisions and help improve patient outcomes.”

According to a release, this is the first Promega companion diagnostic to receive FDA approval.

The approval applies to the United States and its territories.